{"id":346,"date":"2026-08-10T15:55:35","date_gmt":"2026-08-10T13:55:35","guid":{"rendered":"https:\/\/www.pqra.gr\/atmps-the-regulatory-path-for-advanced-therapies\/"},"modified":"2026-08-27T11:41:29","modified_gmt":"2026-08-27T09:41:29","slug":"atmps-the-regulatory-path-for-advanced-therapies","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/atmps-the-regulatory-path-for-advanced-therapies\/","title":{"rendered":"ATMPs: The Regulatory Path for Advanced Therapies"},"content":{"rendered":"<p style=\"font-size:19px;line-height:1.7;color:#33414d;\"><strong>Cell and gene therapies are among the most promising &mdash; and most complex &mdash; medicines in development. Advanced therapy medicinal products follow a dedicated regulatory path, and access remains a significant hurdle.<\/strong><\/p>\n<p>Advanced therapy medicinal products (ATMPs) are governed by Regulation (EC) No 1394\/2007, which sits alongside the general medicines framework as a lex specialis. They fall into three main categories &mdash; <strong>gene therapy<\/strong>, <strong>somatic cell therapy<\/strong> and <strong>tissue-engineered products<\/strong> &mdash; plus combined ATMPs incorporating a medical device.<\/p>\n<h2>The CAT and centralised authorisation<\/h2>\n<p>The Committee for Advanced Therapies (CAT) at the EMA provides scientific classification and prepares draft opinions on ATMP applications. ATMPs follow the <strong>mandatory centralised procedure<\/strong>, resulting in a single EU-wide marketing authorisation.<\/p>\n<h2>The hospital exemption<\/h2>\n<p>Article 28 of the ATMP Regulation allows national authorities to permit a custom-prepared ATMP without a central authorisation, under strict conditions: non-routine preparation, made to prescription for an individual patient, used within the same Member State in a hospital under a doctor&#8217;s responsibility, to national quality standards. Divergent national implementation is a recognised issue, and the EU pharma reform proposes tighter harmonisation.<\/p>\n<h2>Manufacturing under GMP Part IV<\/h2>\n<p>ATMP manufacture follows the dedicated GMP guidelines in EudraLex Volume 4, Part IV &mdash; a risk-based framework tailored to small batches, short shelf lives and, for autologous products, starting material derived from the patient.<\/p>\n<h2>The access challenge<\/h2>\n<p>High one-off costs, uncertain long-term durability data and small patient populations put ATMPs under real strain at the HTA and payer stage. Outcomes-based and managed-entry agreements are common tools. ATMPs are also in scope of the EU Joint Clinical Assessment from January 2025, which may streamline the clinical-assessment step &mdash; though pricing and reimbursement remain national, and in Greece are shaped by budget and clawback pressures.<\/p>\n<h2>How PQRA helps<\/h2>\n<p>PQRA supports ATMP classification, regulatory strategy, and the market-access route through to Greek reimbursement.<\/p>\n<p><strong><a href=\"\/el\/contact\/\">Discuss your advanced therapy &rarr;<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>Cell and gene therapies are among the most promising &mdash; and most complex &mdash; medicines in development. Advanced therapy medicinal products follow a dedicated regulatory path, and access remains a significant hurdle. Advanced therapy medicinal products (ATMPs) are governed by Regulation (EC) No 1394\/2007, which sits alongside the general medicines framework as a lex specialis. [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":364,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"saved_in_kubio":false,"_swpsp_post_exclude":false,"footnotes":""},"categories":[9,10],"tags":[],"class_list":["post-346","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-knowledge-base","category-regulatory-affairs"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ATMPs: The Regulatory Path for Advanced Therapies - PQRA<\/title>\n<meta name=\"description\" content=\"Cell and gene therapies are among the most promising \u2014 and most complex \u2014 medicines in development. 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